Category: Botox and Fillers

A medical study on the safety of the wrinkle relaxer ‘Reloxin’ was just published in the March-April issue of Archives of Facial Plastic Surgery.  The drug was evaluated for use on moderate to severe forehead wrinkles (or glabeller lines), and the results sound optimistic.

The FDA has not yet given its approval for Reloxin to be sold in the U.S., but spokespersons from Medicis Pharmaceutical say clearance is expected late this year.  Reloxin has the potential to become a real competitor for Botox in the U.S. cosmetic surgery market – a market which allowed Allergan Inc. to net $1.3 billion in revenue last year with Botox.

One California dermatologist who participated in the study commented to Bloomberg news, saying “the side effects are the same as Botox” and “many of our patients liked it even better.”

The composition of both Reloxin and Botox is very similar; they each contain a particular ‘botulinum toxin’ that has been proven to relax the muscles that cause wrinkles in the face.

Reloxin has actually been sold overseas under the name ‘Dysport’ for about 15 years, but Botox has still managed to claim over 80 percent of the worldwide market for the neurotoxin.  One market analyst speculates that “Reloxin may be priced 15 percent lower than Botox” which could allow it to take a significant share of that market.

Last week, spokespersons from Radiesse and Bioform Medical Inc. reported that 1 million syringes of Radiesse dermal filler have been shipped since ’02.

Radiesse being the staple product of Bioform, is most commonly used to fill nasolabial folds, wrinkles and correct facial lipoatrophy.  The filler has been marketed for cosmetic and therapeutic use in Europe since 2002.  In 2006 FDA approval for aesthetic facial treatments was granted in the United States, expanding Radiesse’ use beyond therapeutic treatments to include subdermal implantation.

At this time, about ten thousand cosmetic surgery and dermatology practices have used Radiesse – a landmark achievement that cements the company’s position as one of the global market leaders in cosmetic surgery products.  The only comparable fillers with such widespread appeal are those made of collagen or hyaluronic acid, both of which have been on the market longer.

Over the last six years, the United States FDA has received about 900 reports concerning injectable wrinkle-filler complications.  Now as consumer demand for fillers has reached an all-time high, officials have decided to organize a discussion with a panel of outside experts to go over possible changes in labeling of the products.

Those in question are fillers like Radiesse, Juvederm, Restylane, Perlane and others that continue to enter the market.  While it may sound alarming, the complications and side effects associated with these products are extremely rare.  There are well known issues like minor swelling and then there are serious allergic reactions, with the latter being a subject of FDA interest.

According to a recent MSNBC news article, Allergan spokeswoman Caroline Van Hove said “no serious problems were seen in clinical trials of Juvederm, and the most common complaint since its approval was swelling in 0.4 percent of patients.”

Also, Food and Drug Administration officials noted that the “reports had several limitations such as failing to say when the problems started.”  The majority of industry professionals will attribute most reported complications to unqualified persons administering the injections.

Safety and proper training is of the utmost importance with almost any cosmetic procedure, so we recommend that all patients seek a trained and knowledgeable Illinois plastic surgeon with the right qualifications.

For more information on the FDA panel discussion, the briefing is located here.